ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04604184|
Recruitment Status : Terminated (Company decision)
First Posted : October 27, 2020
Last Update Posted : August 3, 2021
This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition.
The purpose of the study is to find out whether a medicine called BI 764198 helps people with COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with COVID-19 infection.
Participants are put into 2 groups by chance. One group of participants gets BI 764198 capsules and the other group gets placebo capsules. The placebo capsules look exactly like the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day.
Participants are in the study for about a month. At study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. During the study, the doctors collect information on any health problems of the participants.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: BI 764198 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)|
|Actual Study Start Date :||November 3, 2020|
|Actual Primary Completion Date :||March 24, 2021|
|Actual Study Completion Date :||May 31, 2021|
|Experimental: Treatment group||
Drug: BI 764198
|Placebo Comparator: Placebo group||
- Patients alive and free of mechanical ventilation [ Time Frame: At Day 29 ]
- Patients alive and discharged free of oxygen [ Time Frame: At Day 29 ]
- Patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation [ Time Frame: At Day 29 ]
- Time to response [ Time Frame: Up to Day 29 ]Clinical improvement of at least 2 points (from randomisation) on the World Health Organization Clinical Progression Scale, discharge from the hospital, or considered fit for discharge (a score of 0, 1, 2, or 3 on the Clinical Progression Scale), whichever comes first. The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead).
- Number of ventilator free days [ Time Frame: Up to Day 29 ]
- Mortality [ Time Frame: At Day 15, 29, 60 and 90 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604184